Recall Z-1278-2015 ยท KXG Applicator, Absorbent Tipped, Sterile
Puritan Medical Products Co., LLC
Puritan absorbent foam tipped applicator; Catalog Number 25-1406 1 PF BT. Sterile absorbent foam tipped applicator used to apply medication or to obtain specimens from a patient.
| Date | Mar 13, 2015 (initiated Dec 22, 2014) |
| Status | Terminated |
| Reason | Shaft breaks so that adequate patient specimen sample cannot be obtained. |
| Root cause | Process control |
| Action | Consignees were initially notified of the recall via phone on 12/23/2014 and 12/29/2014. They were informed that the product may have been over exposed to gamma radiation, resulting in brittle sticks. They were instructed to not use the product for patient sampling and to return any product remaining in inventory to Puritan. |
| Quantity | 9 cases of 500 applicators each |
| Distribution | Distributed in the states of MS, ME, GA, and NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.